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BactiTrap Pipeline Protection Unit / Box of 48
EUDAMEDClass I (EU MDR)
Ref 9970-001
Identity
- Trade Name
- BactiTrap Pipeline Protection Unit / Box of 48 EUDAMED
- Device Name
- Suction System filter, microbial EUDAMED
- Model / Reference
- 9970-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051977000253 EUDAMED
- Basic UDI-DI
- 5051977SCO-BTTG EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose suction system, pneumatic
BactiTrap Pipeline Protection Unit / Box of 48 by Penlon Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose suction system, pneumatic.
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- Furine — Furine ApS · Class I
- Non-sterile aspiration tubes - Flexivac bags — Produtos Médicos Hospitalares, SA · Class I
- VarioAir B BS — Drägerwerk AG & Co. KGaA · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5051977SCO-BTTG | Class I | Active |
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Manufacturer
- Manufacturer
- Penlon Limited
- EUDAMED SRN
- GB-MF-000025115
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 56ce9700-e3bc-4f08-8e90-39b6d7d72b17 61 fields · synced Jul 30, 2026